EP0134671B1 - Anneau à diaphragme contraceptif - Google Patents

Anneau à diaphragme contraceptif Download PDF

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Publication number
EP0134671B1
EP0134671B1 EP84304889A EP84304889A EP0134671B1 EP 0134671 B1 EP0134671 B1 EP 0134671B1 EP 84304889 A EP84304889 A EP 84304889A EP 84304889 A EP84304889 A EP 84304889A EP 0134671 B1 EP0134671 B1 EP 0134671B1
Authority
EP
European Patent Office
Prior art keywords
ring
insert
flexible
diameter
membrane
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP84304889A
Other languages
German (de)
English (en)
Other versions
EP0134671A1 (fr
Inventor
Tapani Luukkainen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Population Council Inc
Original Assignee
Population Council Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Population Council Inc filed Critical Population Council Inc
Priority to AT84304889T priority Critical patent/ATE26533T1/de
Publication of EP0134671A1 publication Critical patent/EP0134671A1/fr
Application granted granted Critical
Publication of EP0134671B1 publication Critical patent/EP0134671B1/fr
Expired legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion

Definitions

  • the present membrane ring overcomes the problems often encountered with conventional diaphragms and provides women with a novel barrier contraceptive which is neat and easy to use for longer periods of time, limits absorption of spermicide by the vaginal mucosa and does not require individual fitting.
  • the membrane ring is a barrier contraceptive device designed to cover the cervical os and thereby prevent the entry of sperm into the uterus. It comprises a flexible ring having a top and buttom surface;
  • the membrane ring as illustrated in Figure 1 generally comprises the flexible ring 10, which has a generally circular shape.
  • the ring can be constructed from any suitable elastomer which is stable, flexible and non-irritating, for example:
  • Thermosetting organopolysiloxanes to be vulcanized with peroxide curing catalysts e.g. benzoyl peroxide or di-p-chlorobenzoyl peroxide at temperatures of about 150-200°C and requiring a heat aftertreatment, e.g. those described in U.S. Patent Nos. 2,541,137; 2,723,966; 2,863,846; 2,891,188 and 3,022,951.
  • Typical curing catalysts are metallic salts of carboxylic acids, preferably tin salts, e.g. tin (II) octoate and tin (11)-2-ethylhexanoate.
  • Single-component silicone rubber compositions which are cured at room temperature under atmospheric humidity without any further additives.
  • These single component compositions contain primarily organopolysiloxanes with two terminal-positioned hydrolyzable acyloxy groups, e.g. acetoxy; the acyloxy groups are hydrolyzed under atmospheric humidity to form trifunctional siloxane units which cross-link the polymer into a cured elastomer.
  • organopolysiloxanes are described, e.g. in U.S. Patent Nos. 2,927,907 and 3,035,016 and in British Patent Nos. 798,669 and 804,199.
  • Two-component dimethylpolysiloxane compositions platinum-catalyzed at room temperature or under slightly elevated temperature and capable of addition cross-linking.
  • the preferred elastomers for use in the membrane ring are polydimethylsiloxanes such as medical grade Silastic rubber. Polyurethanes, natural and synthetic rubbers, copolymers of ethylene and vinyl acetate can also be used.
  • the flexible ring 10 should be of suitable rigidity such that the force needed to cause the inside faces of the ring to touch in response to pressure across the diameter is in the range of 8.9-22.2 N (2-5 lbs.), 13.3-17.8 N (3-4 lbs.) of force being preferred.
  • the ring 10 has a cross-sectional diameter as shown in Figure 2 of about 5-10 mm but preferably 6-8 mm.
  • the ring has an outer diameter 12 of about 50-65 mm, preferably 54-58 mm and an inner diameter 14 of about 30-55 mm, preferably 38-46 mm.
  • the ring has a bottom surface 16 and a top surface 18.
  • the ring can be made by any known means, for example the method of manufacture described in U.S. Patent No. 4,292,965 can be used.
  • a flexible membrane 20 made of sperm impermeable material is stretched across and attached to the bottom surface 16 of the ring to form an essentially flat, sperm impermeable barrier having a top and bottom surface.
  • the flexible membrane 20 can be of any stable, non-irritating, flexible polymer, for example those described above for use in construction of the ring.
  • the membrane can be attached to the ring by any conventional sealing means such as heat sealing or adhesives.
  • An absorbent, flexible, disposable circular insert 22 as illustrated in Figure 4 impregnated with an effective spermicide is placed on top of the flat sperm impermeable flexible membrane 20.
  • the insert 22 has a diameter slightly larger than the inner diameter of the ring 10 and is made of a flexible material that will fold when the ring is compressed for insertion into the vaginal vault but will spring back into place when the pressure on the ring is released. Suitable materials for construction of the insert 22 would include for example cloth, an elastomer, synthetic foams such as polyurethane or collagen and absorbent paper of suitable porosity.
  • the insert 22 is about 30-55 mm in diameter but is about 38-46 mm in diameter in the preferred embodiment.
  • Suitable spermicides for impregnating the insert 22 include, for example, but are not limited to dodecaethylene glycol monolaurate p-methanyl- phenyl polyoxyethylene (8.8) ether (TS-88), methoxypolyoxyethylene glycol 550 laurate, Di- isobutylphenoxy polyethoxy ethanol, polyoxy- ethylenenonyl phenol, phenyl mercuric acetate (PMA), nonoxynol-9, polyethyleneglycol of mono- isoctyl phenol ether, polysaccharidepolysulfuric acid ester, chloramine, sodium dichlorosul- phamidobenzoate, gossypol and its derivatives for example acetates and methyl ethers and benzethonium chloride.
  • the circular insert 22 is held in place on the top surface of the membrane by a flexible permeable cover 24 having a diameter at least equal to the diameter of the insert 22, preferably 38-46 mm.
  • the cover 24 must be flexible enough to return to its original shape after being folded and compressed during insertion of the membrane ring and must be held firmly in place on top of the insert and pressing against the inner circumferences of the ring. This can be accomplished, for example, by fitting the cover 24 with a firm but flexible rim 26 about 2-3 mm in diameter.
  • the rim 26 is separately fastened to the circumferences of the cover by heat sealing, adhesive or any other conventional methods.
  • the rim 26 is formed or molded by conventional means as an integral part of the cover.
  • the cover 24 and rim 26 may be made from any medically suitable flexible material.
  • the rim can also be made from a stable, flexible, non-irritating metal or plastic spring.
  • the insert 22 and the cover 24 are combined into one disposable, flexible, circular cover/insert 28 which is made of the same absorbent material as insert 22.
  • the cover/insert 28 has a diameter at least equal to the diameter of the ring and must be held firmly in place on top of the flexible membrane 20 and pressing against the inner circumference of the ring. This can be accomplished, for example, by fitting the cover/insert with a flexible rim 30 to hold it firmly within the inner circumference of the ring 10.
  • the rim 30 can be formed in the same manner and of the same material as rim 26.
  • the combined cover/insert 28 is impregnated with a suitable spermicide.
  • the membrane ring To position the membrane ring for use, it is folded by applying pressure to both sides of the ring 10 and is placed in the vagina in an open position posterior to the introitus in a manner such that the cover 24 and/or cover/insert 28 covers the cervical os. After use, the ring membrane may be removed in the same manner as a diaphragm.
  • the membrane ring may be fitted with a string or loop 36 to facilitate removal from the vaginal vault after use.
  • the disposable inserts 22 or cover/ insert 28 may also be fitted with a string or loop 38 to facilitate removal and disposal of the inserts after use. After removing the disposable inserts 22 or cover/insert 28 from the ring membrane they are discarded and, the ring membrane is cleaned and stored or fitted with a new insert and repositioned in the vaginal vault.
  • the disposable insert 22 or cover/insert 28 are impregnated with a spermicide and can be supplied already impregnated, for example, individually wrapped in foil or plastic or a larger supply may be stacked and packaged in a sealed wide mouth jar or bottle for easy storage and dispensing.
  • the size of the membrane ring allows it to fit most women and it need not be individually fitted as with a conventional diaphragm. Because child birth usually affects the size of the vaginal vault, the ring is preferably made in two overall diameters; that is, about 50 mm for nulliparous women and about 60 mm for parous women. Because of the design of the ring, the membrane ring is easily retained in the vagina positioned over the cervical os without being readily displaced. It can be left in place for at least twelve hours and it is anticipated that it will remain effective as a contraceptive even after longer periods of use.
  • the spermicide in the membrane ring is actually impregnated in the insert 22 or cover/insert 28 and therefore does not quickly dissipate through leakage as in a conventional diaphragm-spermicide combination.
  • the design of the membrane ring also serves to remove the spermicide from direct contact with the vaginal mucosa which limits absorption of the spermicide through the mucosa.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Glass Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (8)

1. Anneau contraceptif à membrane destiné à recouvrir l'os cervical, qui comprend un anneau flexible (10) ayant une surface de dessus (18) et une surface de dessous (16), une membrane (20) flexible imperméable au sperme étirée au travers de la surface de dessous (16.) de l'anneau et qui y est attachée, un organe d'insertion (22) flexible, jetable reposant sur la membrane (20) imperméable au sperme, l'organe d'insertion étant réalisé en un matériau absorbant et ayant un diamètre légèrement plus grand que le diamètre interne (14) de l'anneau (10), l'organe d'insertion étant de plus imprégné d'un spermicide, et une coiffe (24) perméable flexible placée directement sur le dessus de l'organe d'insertion (22) et pressant contre la circonférence interne de l'anneau, la coiffe ayant un diamètre au moins égal au diamètre interne (14) de l'anneau.
2. Anneau à membrane selon la revendication 1, dans lequel la coiffe (24) et l'organe d'insertion (22) sont combinés pour former un ensemble (28) organe d'insertion/coiffe flexible jetable qui comprend un organe d'insertion flexible préimprégné d'un spermicide.
3. Anneau à membrane selon la revendication 2, dans lequel l'ensemble organe d'insertion/ coiffe (28) est muni d'un rebord flexible (30) pour le maintenir solidement à l'intérieur de la circonférence interne de l'anneau.
4. Anneau à membrane selon la revendication 1, dans lequel la coiffe (24) est munie d'un rebord flexible (26) pour la maintenir solidement à l'intérieur de la circonférence interne de l'anneau.
5. Anneau à membrane selon la revendication 1, dans lequel l'anneau est muni de moyens (36) pour faciliter son enlèvement.
6. Anneau à membrane selon la revendication 2, dans lequel l'anneau est muni de moyens pour faciliter son enlèvement.
7. Anneau à membrane selon la revendication 1, dans lequel l'anneau (10) présente un diamètre en coupe transversale d'environ 5-10 mm, un diamètre externe (12) d'environ 50-65 mm et un diamètre interne (14) d'environ 30-55 mm; l'organe d'insertion (22) a un diamètre d'environ 30-55 mm, et la coiffe (24) présente un rebord flexible (26) d'environ 2-3 mm de diamètre.
8. Anneau à membrane selon la revendication 2, dans lequel l'anneau présente un diamètre en coupe transversale d'environ 5-10 mm, un diamètre externe d'environ 50-65 mm et un diamètre interne d'environ 30-55 mm; l'ensemble organe d'insertion/coiffe (28) a un diamètre d'environ 30-55 mm et présente un rebord flexible (30) d'environ 2-3 mm de diamètre.
EP84304889A 1983-07-19 1984-07-18 Anneau à diaphragme contraceptif Expired EP0134671B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT84304889T ATE26533T1 (de) 1983-07-19 1984-07-18 Empfaengnisverhuetender membranring.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US51534383A 1983-07-19 1983-07-19
US515343 1983-07-19

Publications (2)

Publication Number Publication Date
EP0134671A1 EP0134671A1 (fr) 1985-03-20
EP0134671B1 true EP0134671B1 (fr) 1987-04-15

Family

ID=24050952

Family Applications (1)

Application Number Title Priority Date Filing Date
EP84304889A Expired EP0134671B1 (fr) 1983-07-19 1984-07-18 Anneau à diaphragme contraceptif

Country Status (4)

Country Link
EP (1) EP0134671B1 (fr)
AT (1) ATE26533T1 (fr)
DE (1) DE3463119D1 (fr)
FI (1) FI82885C (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8919345B2 (en) 2012-06-29 2014-12-30 Robert Clark Avery, Jr. Method of overwrapping a pessary device
US10226387B2 (en) 2014-09-19 2019-03-12 Gwynne Marie Hite Cervical pad

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6264638B1 (en) 1989-12-07 2001-07-24 Ultrafem, Inc. Intravaginal drug delivery system and discharge collection device
US5295984A (en) * 1989-12-07 1994-03-22 Ultrafem, Inc. Vaginal discharge collection device and intravaginal drug delivery system
IL127880A0 (en) 1996-07-03 1999-10-28 Ultrafem Inc Method and system for manufacturing elastomeric articles
US7845355B2 (en) 2005-05-19 2010-12-07 Reprotect, Inc. Intravaginal device with improved rim designs and methods of making same

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE574471C (de) * 1933-07-19 Emil Muehler Haubenfoermiges Pessar
DE463331C (de) * 1928-07-26 Willy Reusch Dr Okklusivpessar
DE355944C (de) * 1920-10-24 1922-07-10 Julius Frankenstein Dr Okklusivpessar
US2145057A (en) * 1937-05-18 1939-01-24 Schmid Julius Pessary
US3015598A (en) * 1958-11-03 1962-01-02 Jones John Leslie Manufacturing absorbent diaphragms
US3128767A (en) * 1962-07-16 1964-04-14 James J Nolan Vaginal tampon device incorporating membrane for substantially blocking inflow of water
US3216422A (en) * 1962-11-23 1965-11-09 Johnson & Johnson Vaginal tampon
US3786807A (en) * 1972-02-29 1974-01-22 D Dubin Disposable diaphragm and insertion-removal unit therefor
US3983874A (en) * 1975-06-26 1976-10-05 Davis Alwyn K Catamenial diaphragm with replaceable tampon
US4198976A (en) * 1977-10-11 1980-04-22 The Procter & Gamble Company Vaginal contraceptive
US4300544A (en) * 1978-09-05 1981-11-17 Dia-Sert Corp. Disposable female contraceptive
US4200090A (en) * 1979-01-15 1980-04-29 The Procter & Gamble Company Vaginal contraceptive and method of using
US4369773A (en) * 1980-11-05 1983-01-25 Milos Chvapil Contraceptive sponge - diaphragm bilayer

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8919345B2 (en) 2012-06-29 2014-12-30 Robert Clark Avery, Jr. Method of overwrapping a pessary device
US9433523B2 (en) 2012-06-29 2016-09-06 The Procter & Gamble Company Method of overwrapping a pessary device
US10226387B2 (en) 2014-09-19 2019-03-12 Gwynne Marie Hite Cervical pad

Also Published As

Publication number Publication date
EP0134671A1 (fr) 1985-03-20
FI82885C (fi) 1991-05-10
FI842652A (fi) 1985-01-20
DE3463119D1 (en) 1987-05-21
FI82885B (fi) 1991-01-31
FI842652A0 (fi) 1984-07-02
ATE26533T1 (de) 1987-05-15

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